DRUG DISCOVERY AND DEVELOPMENT GRADUATE PROGRAM Policies & Procedures *Please note that these policies are subject to change; students will be notified of any changes. Department of Pharmacology & Physiology Graduate Program in Drug Discovery & Development Drexel University College of Medicine Room 8304, NCB 245 N. 15th Street Philadelphia, PA 19102 TEL: 215-762-4530 FAX: 215-762-4850 Revised: 8/2014 1 TABLE OF CONTENTS Pages I. INTRODUCTION 3 II. OBJECTIVES 3 III. BASIC GUIDELINES FOR MS DEGREE 3 A. Course Requirements 3 B. Curriculum 4 C. Laboratory Rotations 5 D. Elective Courses 5 1. College of Medicine 2. School of Biomedical Engineering 3. School of Public Health 4. LeBow College of Business 5. Professional Studies Program 6 6 6 7 7 E. Internships 7 IV. THESIS TRACK 7 A. Thesis Requirements 7 B. Thesis Advisory Committee 7 C. Thesis Proposal 8 D. Thesis Defense 8 V. NON-THESIS TRACK 9 A. Course Requirements 9 B. Scholarly Review 9 C. Advisory Committee 9 D. Review Proposal 10 E. Review Evaluation 10 CODE OF BEHAVIOR 11 CODE OF ETHICS 11 I. INTRODUCTION 2 The Graduate Program offers coursework and research opportunities leading to the MS degree in Drug Discovery and Development. The overall goal of this Program is to provide students with an intensive multifaceted classroom experience along with diverse research avenues to prepare graduates for career opportunities in the pharmaceutical and biotech industries. There are several requirements that are necessary to obtain a MS degree in this program and they are described below. The Program’s foundation is in the biomedical sciences with an initial emphasis on the disciplines of Pharmacology and Physiology. A main concentration will be on providing an in-depth focus on the detailed and complex processes involved in drug discovery and development. The program includes resident faculty from the Department of Pharmacology & Physiology and other programs, faculty with experience in the pharmaceutical and biotechnology industry, as well as scientists and executives from various pharmaceutical and biotechnology companies. The Program will cover all aspects involved in the discovery, development and commercialization of drugs. Depending on a student’s preferences, there are multiple options and areas of concentration that can be pursued using elective courses in different departments, schools and colleges. This booklet describes academic policies and procedures pertaining to graduate study in the Drug Discovery and Development Graduate Program. The information in this booklet supplements procedures and general rules of the Office of Biomedical Graduate Studies and contains current guidelines that are revised periodically by faculty in the Program. II. OBJECTIVES The purpose of this Program is to provide academic training and research opportunities enabling in-depth exposure to the multiple elements associated with drug discovery and development. By increasing one’s knowledge in this area, this Program will provide additional career options to graduating students. This degree will also be available to individuals seeking to better understand as well as increase their base of knowledge in this area to enhance their career advancement opportunities. The Program has been designed with the recognition that the pharmaceutical and biotechnology industries are complex, are constantly evolving, and require a diversity of expertise. We have tapped into the rich and diverse resources available within the Drexel University academic community to draw on courses available in the LeBow School of Business, the School of Public Health and other departments and schools and have also successfully attracted individuals from all levels and sectors of the pharmaceutical industry to participate in the development of the program. This Program will provide students with a core, detailed focus on the many facets of Drug Discovery and Development while simultaneously providing those students with multiple options to pursue related areas of interest. III. BASIC GUIDELINES FOR THE MS DEGREE A. Course Requirements All students in the Drug Discovery and Development Program are required to take the following programmatic courses in the first year: Drug Discovery and Development I and II, Graduate Physiology, and Advanced Topics in Physiology. In the second year, students must take Graduate Pharmacology and Advanced Topics in Pharmacology. In addition, students must take Scientific Integrity and Ethics and Biostatistics or Statistics for Neuro/Pharm Research. All students must register and participate in the seminar/discussion course (Journal Club) Current Topics in Pharmacology and Physiology every semester while in the program up until registering for Thesis Defense. It is expected that each student will complete at least one research rotation 3 in Drug Discovery and Development Research. The Program Director will advise each student on the selection of the flexible aspects of the curriculum such as choice of electives. B. Curriculum First Year Fall Semester PHRM-525 Drug Discovery and Development I PHGY-503 Graduate Physiology PHRM-518 Advanced Topics in Physiology IDPT-500 Responsible Conduct of Research PHRM-502 Current Topics in Pharmacology & Physiology Total credits: 3 credits 4 credits 1 credits 2 credits 1 credit 11 credits First Year Spring Semester PHRM-526 Drug Discovery and Development II NEUR-500 Statistics for Neuro/Pharm Research* PHRM-504 Research in Drug Discovery and Development PHRM-502 Current Topics in Pharmacology & Physiology Elective Total credits: 3 credits 2 credits 4 credits 1 credits 3 credits 13 credits The Drug Discovery and Development Program Director will serve as Advisor to New Graduate Students and meet with them once during the Fall and Spring semesters of the first year of study. *Statistics requirement may be met by taking Biostatistics (IDPT-501). Second Year Fall Semester PHRM-512 Graduate Pharmacology PHRM-516 Advanced Topics in Pharmacology PHRM-502 Current Topics in Pharmacology & Physiology Elective 1 Elective 2 Total credits: Second Year Spring Semester PHRM-600 Pharmacology & Physiology Thesis Research OR PHRM-520 Internship in Drug Discovery and Development PHRM-503 Pharmacology & Physiology Lab Rotation PHRM-502 Current Topics in Pharmacology & Physiology Total credits: 4 3 credits 1 credits 1 credits 3 credit 4 credits 12 credits 9 credits 4 credits 4 credits 1 credit 9 credits ^The student is required to take 2 graduate level elective courses chosen with advice from the Program Director and/or the Research Advisor. The Office of Biomedical Education has established criteria by which all students in all graduate programs will be uniformly evaluated. A grade of B must be earned in each required course. Programmatic courses must be repeated if the student earns a grade below a B in that particular course. Programmatic courses in which a student has earned a grade of B- can be remediated to a B. Students must maintain a grade point average of at least 3.0. If their average falls below 3.0, they will automatically be placed on academic probation. Performance Criteria for Current Topics in Pharmacology & Physiology Three unexcused absences are allowed per year for journal clubs. More than three absences will result in a grade of Unsatisfactory (U). The “U” must be remediated to the satisfaction of the course director. C. Laboratory Rotations Laboratory rotations must be arranged in consultation with the Program Director and faculty of the Program. The research areas may be chosen to complement the student's long-term research interests. Research rotations should provide an opportunity to: • • • • • Practice scientific logic and experimental design Acquire useful technical expertise Extend scientific and personal interactions within and between labs Explore the possibility for a future Thesis research topic Develop presentation skills At least 20 hours per week (minimum) for a three-month period are required for each rotation. An oral presentation of the research experience is prepared by the student at the end of each rotation, presented to the department and evaluated by the faculty and the student. Students must complete a rotation evaluation form with their mentor upon completion of their rotation which must be filed with the Program Director and the Biomedical Graduate Studies office. Performance Criteria for Laboratory Rotations Laboratory rotations are graded on a Satisfactory (S) or Unsatisfactory (U) basis. Students receiving an “S” are rated on a performance scale ranging from Outstanding (1) to Poor (5). A “U” for a lab rotation is reserved for students that do not meet performance requirements, including attendance, of the rotation as stipulated by the program. D. Elective Courses In consultation with the student’s advisor and according to the anticipated area of interest, the student is required to select a minimum of 2 elective courses from a diverse range of topics that complement the core curriculum and which provide relevant, in-depth knowledge to enhance career options. The two elective courses can be taken as appropriate throughout the student’s training. Courses outside of the Drug Discovery and Development program may be taken on the advice and with the permission of the Program Director and the faculty mentor. 5 A list of potential electives is provided below. This is a representative list and students are not limited to selecting from this list of electives. It is recommended that you consult with the course director for each course to receive approval to register for the course and to determine if there are prerequisites or class limitations. For courses outside the College of Medicine, please consult the Graduate catalog at http://catalog.drexel.edu/coursedescriptions/quarter/grad/ Advanced Elective Courses: 1. College of Medicine credits Pharmacology & Physiology PHRM-516 Methods in Biomedical Research PHRM-520 Internship in Drug Discovery and Development PHRM-518 New Frontiers in Therapy PHRM-507 Principles of Neuropharmacology PHRM-503 Pharmacology & Physiology Lab Rotation 3 4 3 3 4 Neuroscience NEUR-512 NEUR-508 1.5 2.5 Advanced Cellular & Systems Neurophysiology Graduate Neuroscience I Microbiology & Immunology MIIM-630 Advanced Molecular Biology MIIM-521 Biotechniques MIIM-613 Emerging Infectious Diseases MIIM-530 Fundamentals of Molecular Medicine I MIIM-531 Fundamentals of Molecular Medicine II MIIM-508 Immunology I MIIM-512 Molecular Pathogenesis I MIIM-524 Vaccines & Vaccine Development 2 2* 2 2-3 2 3 3 3* Biochemistry BIOC-510 3 Cancer Biology Molecular Pathobiology PATH-601 Cell & Molecular Biology of Cancer 4 2. School of Biomedical Engineering & Health Sciences BMES-588 BMES-604 BIO-631 Medical Device Development Pharmacogenomics Bioinformatics 3 3 3 Introduction to Public Health Principles of Epidemiology 2 4 3. School of Public Health PBHL-516 PBHL-530 6 4. LeBow College of Business BUSN-601 BUSN-602 MGMT-685 MGMT-910 PROJ-501 PROJ-535 MGMT-940 ORGB-625 Health Care Law and Pharmaceutical Regulations Business Strategies in Drug Development Implementing Strategies Using Project Teams Readings in Strategic Management Introduction to Project Management International Project Management Seminar in Organizational Behavior Leadership and Professional Development 3 3 3 3 3 3 3 3 5. Professional Studies Program MLAS-536 Animal Models for Biomedical Research 1* *Restrictions apply NOTE: Courses in the Schools of Public Health and Biomedical Engineering & Health Sciences as well as the LeBow College of Business are offered on a quarter, not semester, schedule E. Internships An internship is a critical component of the training program in Drug Discovery and Development and provides a unique opportunity for the student to apply the didactic knowledge gained in the laboratory in a professional setting. The internship experience can be utilized to obtain specialized training in an branch of the field that the student intends to pursue after graduation or it can provide valuable diversification to a student’s background. Internships may be arranged with pharmaceutical companies, biotech companies, contract research organizations, foundations, government agencies or academic institutions. Several of these organizations have established formal internship or co-op programs that would be appropriate for this experience. Students are expected to arrange an internship with the assistance of the Program faculty to take place over the summer or during the Spring semester of their 2nd year. IV. THESIS TRACK A. Thesis Requirement The thesis project need not be independent but rather must be at the suggestion and guidance of the major advisor. The project must be appropriate for completion and thesis defense no later than August of the second year. Laboratory work can begin during the summer after the first year and continue through the second year. B. Thesis Advisory Committee By the end of the third semester, the student will propose members of the faculty to serve on the Thesis Advisory Committee subject to approval by the Program Director. Once formed, this committee will meet every three months to review the student’s progress. The committee consists of at least three voting members who must be Graduate School faculty from the Drug Discovery and Development or Pharmacology & Physiology Graduate Programs. The student’s major advisor is a voting member of the Committee but cannot chair the Committee. The Chair of the Committee must not be a collaborator on the student’s research project and must not have any apparent conflicts of interest related 7 to the publication or funding of the student’s project. It is also the responsibility of the Chair to ensure that there is sufficient balance on the committee to ensure a rigorous and unbiased critique of the student’s project and progress. Following the quarterly review by the Committee, a brief statement of the student’s progress must be signed by each Committee member and submitted to the Program Director. C. Thesis Proposal 1. Master’s degree students will present their thesis proposal to their thesis advisory committee. The Thesis Proposal document will be submitted by the student after completion of the Fall semester courses of the 2nd year of study. Under special circumstances this can be extended (no more than 6 months but all proposals for extensions will be given due consideration; approval must be obtained through written request to the Program Director). The Thesis Proposal must include an abstract and planned table of contents and be handed in one week prior to the formal presentation of the Thesis Proposal to his/her Thesis Advisory Committee unless otherwise specified by the Chair of the Committee. Upon approval of the Thesis Proposal the student will continue with his/her thesis research, culminating with the presentation of the MS thesis for defense. 2. At the time of the proposal the student will present a brief (10-15 minute) oral summary of his/her intended research project followed by a detailed question and answer session with the Thesis Advisory Committee. 3. The Thesis Advisory Committee will then reach a decision. If the decision is positive, the student may continue with his/her thesis research. If the decision is negative, the student can re-submit a revised or new proposal in one month. If the Thesis Proposal is rejected a second time, the student will be recommended for a non-thesis Master’s degree. D. Thesis Defense 1. A written thesis is required with an oral defense before the thesis advisory committee. A candidate may not present him/herself for the final thesis defense until he or she has completed at least 12 calendar weeks of residence after satisfactory completion of the Thesis Proposal, and has the approval of his/her major advisor. 2. At least four weeks prior to the date of the thesis defense, the Chair of the Committee, or the Program Coordinator must notify the Office of Biomedical Graduate Studies, the Registrar’s Office and all departments involved in graduate education of the scheduled date of the thesis defense. At least two weeks prior to the date of the defense, typewritten or photocopies of the thesis must be distributed to each member of the advisory-examination committee. 3. The thesis defense will take place no less than two weeks and no more than four weeks after the thesis has been distributed to the members of the examination committee, except under written direction of the Steering Committee. 4. The thesis defense will be public. The candidate will be formally introduced by his/her advisor or the Chair of the Committee. The candidate will present a 30-minute seminar on his/her research, followed by questions from the Examination Committee and the general audience. After this initial question and answer period, the chair will dismiss the audience. The Examination Committee will meet in private with the candidate to complete the examination process. 5. The Thesis Examination Committee shall decide upon the merits of the candidate’s performance on the thesis defense. To be recommended for a Master’s degree, the candidate must receive unanimous approval of the Committee. By permission of the Committee a candidate who has failed the final thesis defense may present him or herself for re-examination after one, but not more than six months. This reexamination must be taken within a calendar year of failure to pass the first examination. A report on each 8 final thesis defense whether passed, failed, or recommended for re-examination must be filed by the Committee in the Office of Biomedical Graduate Studies. 6. Three copies of the completed thesis suitable for binding and bearing the approval of the advisoryexamination Committee must be deposited in the Office of Biomedical Graduate Studies. One of these copies is to be placed on file in the COM Library, Graduate Office and the Pharmacology & Physiology Main Office. An unbound copy of the thesis must also be presented to the Office of Biomedical Graduate Studies for microfilming by University Microfilms, Ann Arbor Michigan. The abstract will be published in Dissertation Abstract by University Microfilms. The cost of preparation, reproduction and personal binding copies are the candidate’s responsibility. V NON-THESIS TRACK A. Course Requirements The Drug Discovery and Development Program offers a non-thesis MS degree in which students can earn the degree by taking graduate classes and writing a literature review paper as opposed to conducting original research. The requirements for a MS degree without thesis are essentially the same as those described above except that preparation of a scholarly review is required in lieu of a research-based thesis. The student is encouraged to choose a faculty or external mentor no later than the end of the Fall semester of the second year. External mentors must be approved by the Program Director who will help to insure that the student is making adequate progress. The role of the mentor is to provide guidance in selecting the topic for the scholarly review, and in helping the student perform the literature search, and, in writing the document. The selected topic must be approved by the Scholarly Review Advisory Committee. B. Scholarly Review The scholarly review covers a topic in detail based on primary research literature. The body of the paper must be 35-50 double spaced pages (12 pt font). This page number does not include citations but citations must be provided as well. The following format must be followed: • Abstract (250 words) • Body of Paper • Introduction – what is the purpose and scope of the review • Literature review – review and contrast findings in the field; identify unresolved issues and shortcomings of technical approaches • Summary – what are the key findings of the review • Conclusion- what gaps in our knowledge or unanswered questions emerge from the review; what are potential future directions for research in this area. Successful completion of the literature review will be subject to the approval of the mentor/advisor and the Advisory Committee. The student is strongly encouraged to produce a document of sufficient quality to merit consideration for publication. C. Scholarly Review Advisory Committee By the end of the third semester, the student will propose members of the faculty to serve on the Advisory Committee subject to approval by the Program Director. Once formed, this committee will meet every three months to review the student’s progress. The committee consists of at least three voting members who must be Graduate School faculty from the Drug Discovery and Development or 9 Pharmacology & Physiology Graduate Programs. The student’s major advisor is a voting member of the Committee but cannot chair the Committee. It is also the responsibility of the Chair to ensure that there is sufficient balance on the committee to ensure a rigorous and unbiased critique of the student’s project and progress. Following the quarterly review by the Committee, a brief statement of the student’s progress must be signed by each Committee member and submitted to the Program Director. D. Scholarly Review Proposal 1. Master’s degree students will present their Review Proposal to their advisory committee. The Proposal document will be submitted by the student after completion of the Fall semester courses of the 2nd year of study. Under special circumstances this can be extended (no more than 6 months but all proposals for extensions will be given due consideration; approval must be obtained through written request to the Program Director). The Review Proposal must include an abstract and planned table of contents and be handed in one week prior to the formal presentation of the Proposal to his/her Advisory Committee unless otherwise specified by the Chair of the Committee. Upon approval of the Proposal, the student will continue with his/her literature research, culminating with the presentation of the Review. 2. At the time of the proposal the student will present a brief (10-15 minute) oral summary of his/her intended Review followed by a detailed question and answer session with the Advisory Committee. 3. The Advisory Committee will then reach a decision. If the decision is positive, the student may continue with his/her literature research. If the decision is negative, the student can re-submit a revised or new proposal in one month. E. Scholarly Review Evaluation 1. A written review is required with an oral presentation before the advisory committee. A candidate may not present him/herself for the final presentation until he or she has completed at least 8 calendar weeks of residence after satisfactory completion of the Proposal, and has the approval of his/her advisor. 2. At least two weeks prior to the date of the defense, typewritten or photocopies of the scholarly review must be distributed to each member of the advisory committee. 3. The presentation will take place no less than two weeks and no more than four weeks after the written review has been distributed to the members of the committee except under written direction of the Program Director. 4. The presentation will be public. The candidate will be formally introduced by his/her advisor or the Chair of the Committee. The candidate will present a 30-minute seminar on his/her review topic, followed by questions from the Advisory Committee and the general audience. After this initial question and answer period, the chair will dismiss the audience. The Advisory Committee will meet in private with the candidate to complete the evaluation process. 5. The Advisory Committee shall decide upon the merits of the candidate’s performance on the presentation and knowledge of the material. To be recommended for a Master’s degree, the candidate must receive unanimous approval of the Committee. By permission of the Committee a candidate who has failed the final evaluation may present him or herself for re-evaluation after one, but not more than six months. 10 CODE OF BEHAVIOR The Graduate Program in Pharmacology & Physiology subscribes to the Code of Professionalism (http://www.drexelmed.edu/Portals/0/BiomedicalGraduateStudies /StudentHandbook2010.pdf) for all of its members. This policy states that professional behavior appropriate to a faculty and students in an academic research setting is expected and required at all times. Admission to and continued participation in the Graduate Program is therefore contingent upon the student's understanding of this policy, and his/her agreement to adhere to its guidelines. CODE OF ETHICS The Graduate Program in Pharmacology & Physiology subscribes to the Code of Academic Integrity (presented in its complete form in the Student Handbook, (http://www.drexelmed.edu/Portals/0/BiomedicalGraduateStudies/StudentHandbo ok2010.pdf) for all its members. This policy states that cheating, plagiarism, forgery, or other forms of academic misconduct are not tolerated at our institution. Admission to and continued participation in the Graduate Program is therefore contingent upon the student's understanding of this policy, and his/her agreement to adhere to its guidelines. 11